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Breast Cancer Clinical Trial to Use Biovica Test

NEW YORK – Biomarker test developer Biovica said today that it has inked an agreement with the SWOG Cancer Research Network to study the clinical benefit of its DiviTum immunoassay using blood samples from women with metastatic hormone receptor-positive breast cancer.

Biovica said that under the agreement, investigators will use its CE-marked DiviTum assay to analyze samples from participants in the SWOG 0226 clinical trial, which demonstrated that women with metastatic hormone receptor-positive breast cancer live longer when they receive a combination of two anti-estrogen drugs. Trial investigators enrolled 707 postmenopausal women with metastatic breast cancer at 73 hospitals, clinics, and cancer centers across the US and Canada between 2004 and 2009.

Uppsala, Sweden-based Biovica said that investigators will evaluate new data about DiviTum as well as the clinical trial treatment outcomes to determine whether the assay can accurately predict treatment response in the metastatic hormone receptor-positive breast cancer patients.

Biovica CEO Anders Rylander said in a statement that the firm plans to use the results of the study as the backbone of a submission to the US Food and Drug Administration for 510(k) clearance of DiviTum.

The DiviTum biomarker immunoassay measures the activity of the thymidine kinase-1 (TK) enzyme in a blood sample. TK activity is highly associated with the rate of cell proliferation, making it a particularly suitable biomarker for measuring tumor aggressiveness, according to Biovica.

The S0226 trial was officially closed to enrollment in July 2009. The New England Journal of Medicine has published the first results and extended follow-up results.